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The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan + Lacidipine - low dose | Experimental |
| |
| Telmisartan + Lacidipine - medium dose | Experimental |
| |
| Telmisartan + Lacidipine - high dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 72 hours after drug administration | |
| Number of subjects with adverse events | up to 72 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (Area under the concentration-time curve of the analyte in plasma) | up to 72 hours after drug administration | |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 72 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| C060285 | lacidipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Lacidipine |
| Drug |
|
| Placebo | Drug |
|
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) | up to 72 hours after drug administration |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | up to 72 hours after drug administration |
| MRT (Mean residence time of the analyte in the body) | up to 72 hours after drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 72 hours after drug administration |
| Number of subjects with abnormal changes in laboratory parameters | up to 72 hours after drug administration |
| Number of subjects with clinically significant changes in vital signs | up to 72 hours after drug administration |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |